FDA Device recall Z-2201-2025
Achieva XR
- FDA Device
- Class II
- ongoing
- Published 2025-08-06
On 2025-08-06 the FDA classified a Class II recall of Achieva XR by Philips North America, citing the potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2201-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-30 |
| Published | 2025-08-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;
Reason
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Identifiers
| code_info | Model Numbers (REF): (1) 781153, (2) 781253; UDI-DI: (1) None, (2) None; Serial Numbers: (1) 23003, 23004, 23005, 23011…Model Numbers (REF): (1) 781153, (2) 781253; UDI-DI: (1) None, (2) None; Serial Numbers: (1) 23003, 23004, 23005, 23011, 23014, 23017, 23020, 23021, 23028, 23031, 23035, 23041, 34039, (2) 35004, 35006, 35007, 35011, 35015, 35016, 35019, 35020, 35021, 35022, 35028, 35035, 35049, 35050, 35061, 35063, 35067, 35068, 35069, 35070, 35074, 35075, 35076, 35081, 35083, 35084, 35085; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2201-2025%22
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